The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy

July 25, 2016 updated by: Sara Asghari Kaleibar, Istanbul University

The Effects of Virtual Reality Therapy Compared With Home Exercise Program on Upper Extremity Functions in Children With Hemiplegic Cerebral Palsy: a Randomized Controlled Trial

The investigators have planned a research on the effects of virtual reality therapy and home exercise program on hand functions in children with hemiplegic cerebral palsy in Istanbul University Istanbul Faculty of Medicine in the Department of Physical Medicine and Rehabilitation. The eligible patients will be randomized into two groups. The patients in intervention group will participate in a computer based virtual reality exercise program for a period of 8 weeks supervised by the investigators. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The current study is a prospective, randomized controlled interventional trial, which will conduct in the Istanbul University Istanbul Faculty of Medicine in 2016. The study was approved by the Ethics Committee in conformity with the Declaration of Helsinki. Prior to data collection, all participants will provide informed consent. By the order of application to the outpatient clinics, the eligible participants will randomly allocated to two groups using the computer-generated random numbers: intervention group (n=17) and control group (n=17). Information on demographic characteristics (age, gender, body mass index, educational level), pre-natal history, parent educational level and past medical history will obtain at baseline assessment. After baseline assessment, the patients in intervention group will participate in a computer based virtual reality exercise program with HandTutor equipment. The supervised intervention program consists of a forty-minute exercise session three times a week for 8 weeks. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. The home exercise program consists of different games and exercises such as range of motion, stretch, and strengthening exercises for hand. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Recruiting
        • Istanbul Faculty of Medicine
        • Contact:
          • Sara Asghari Kaleibar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with hemiplegic cerebral palsy diagnosed by the specialist
  • Active wrist extension ≥ 20 °
  • Gross Motor Function Classification System score: 1-2
  • Manual Ability Classification System score: 1-3
  • The ability to follow simple commands and participate in the task

Exclusion Criteria:

  • Contracture in upper limb
  • Absence of vision and hearing problems
  • Uncontrolled seizure
  • Lack of movement in the hemiplegic upper limb
  • History of orthopedic surgery (tendon transfer / tendon lengthening) to the affected upper extremity
  • Any treatment for upper limb in the last 6 months including BTX-A or orthopedic interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Virtual reality exercises using Hand Tutor for 8 weeks
Other: Virtual Reality Exercises using Hand Tutor
Virtual reality technology is rapidly becoming a popular application for physical rehabilitation and motor control research. The prototype, which includes a built-in movement sensor, allows the user to do controlled exercises as part of a rehabilitation program. The supervised intervention program consists of a forty-minute exercise session three times a week for 8 weeks. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. The home exercise program consists of different games and exercises such as range of motion, stretch, and strengthening exercises for hand.
No Intervention: Control
Home exercises for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisting Hand Assessment (AHA)
Time Frame: Within 7 Days
AHA measures are valid and reliable for children aged between 18 months and 12 years with the diagnosis of unilateral cerebral palsy. It measures how effectively children with unilateral hand dysfunction use their involved hand in collaboration with their uninvolved hand to perform bimanual tasks.The test is administered in two steps. First, a video-recorded play session lasting 10 to 15 minutes is conducted with specific toys from the AHA test kit.Second, the scoring is performed by a review of the video on 22 items by certificated professional. The AHA version 4.4 includes 22 test items each rated on a 4-point scale, with a total raw score range between 22-88 points. The higher score indicating higher ability.
Within 7 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Grip Measurement
Time Frame: Within 7 Days
Grip strength will measured with BASELINE Dynamometer. The participants will seat and the shoulder is hold in the adducted and minimally internal rotated, elbow flexed at 90 degrees, forearm in natural position and wrist flexed between 0 and 30 degrees (Kg/f).
Within 7 Days
ABILHAND
Time Frame: Within 7 Days
ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs. 21 manual activities perceived by the children parents. Each item is answered on a 3-level scale (impossible, difficult, easy). The Parent is asked to fill in the questionnaire by estimating their child's performance independent of the limb the child actually. The online analysis converts the raw scores into a linear measure of manual ability. ABILHAND-Kids has been validated in cerebral palsy children (age 6-15).
Within 7 Days
Range of Motion (ROM)
Time Frame: Within 7 Days
By using the Universal Goniometer, the active and passive ROM will be assessed based on the 360-degrees system in radioulnar pronation and supination, wrist flexion and extension, 2nd to 5th metacarpophalangeal joints
Within 7 Days
Modified Ashworth Scale (MAS)
Time Frame: Within 7 Days
One of the methods for measuring muscle spasticity includes manually moving a limb through its ROM to passively stretch specific muscle groups. Modified Ashworth Scale for Grading Spasticity is six-point scale (0-5).
Within 7 Days
TARDIEU SCALE
Time Frame: Within 7 Days

Tardieu Scale (TS):

It assesses the response of the muscle to passive movement of limb in both slow and fast speeds, on the other word it evaluated velocity dependent muscle tonicity. Intensity of muscle reaction (Y) is included six-point scale (0-5)
Within 7 Days
Pulp Pinch Strength Measurement
Time Frame: Within 7 Days
Pulp pinch strength is measured by the "JAMAR Hydraulic Pinch Gauge" which evaluates the pinch strength between first and second digits. The participants will seat and the shoulder is hold in the adducted and minimally internal rotated, elbow flexed at 90 degrees, forearm in natural position and wrist flexed between 0 and 30 degrees (Kg/f).
Within 7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Resa Aydin, MD, Prof, Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 21, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKaleibar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We have no permission to share individual participant data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Virtual Reality Exercises using Hand Tutor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe